Merck's WELIREG® Phase 3 Trial Shows Promising Results in Advanced Renal Cell Carcinoma

Merck has announced positive Phase 3 trial results for WELIREG (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in the treatment of advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. The trial showed statistically significant improvements in progression-free survival (PFS) compared to everolimus, as well as a significant improvement in objective response rate (ORR). While there was a trend towards improvement in overall survival (OS), it did not reach statistical significance. The safety profile of WELIREG was consistent with previous studies.